AbbVie has announced the US Food and Drug Administration (FDA) approval of Rinvoq (upadacitinib) for moderate to severe active rheumatoid arthritis (RA).
In the SELECT programme, the oral JAK inhibitor met all primary and ranked secondary endpoints across a variety of patients with moderately to severely active rheumatoid arthritis, and significantly inhibited radiographic progression even without methotrexate.
The study was one of the largest registrational Phase III programs in RA with approximately 4,400 patients evaluated across all treatment arms in five studies, which included assessments of efficacy, safety and tolerability across a variety of RA patients, including those who failed or were intolerant to biologic disease-modifying anti-rheumatic drugs and who were naive or inadequate responders to methotrexate. Rinvoq is not indicated for methotrexate-naive patients.
"Despite the availability of multiple treatment options with varying mechanisms of action, many patients still do not achieve clinical remission or low disease activity—the primary treatment goals for rheumatoid arthritis," said Roy M. Fleischmann, primary investigator for SELECT.
He continued, "With this FDA approval, Rinvoq has the potential to help additional people living with RA achieve remission who have not yet reached this goal."
Rheumatoid arthritis is a long-term condition that causes pain, swelling and stiffness in the joints. The symptoms usually affect the hands, feet and wrists.
Some people with rheumatoid arthritis also experience problems in other parts of the body, or more general symptoms such as tiredness and weight loss.